薬学および生命科学における研究開発の国際ジャーナル

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REGULATORY AFFAIRS IN THE PHARMACY CURRICULUM

Sumit Kumar, Rishabh Panwar, Upendra Singh

Indian pharmaceutical sector is rising very rapidly and there is a want of regulatory affairs professionals to provide the current needs of industries for the global competition. A regulatory affair is a somewhat new profession which has developed from the desire of governments to defend public health. The areas where government controlling the safety and efficacy of products are pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The pharmaceutical companies responsible for the discovery, testing, clinical trials, production, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies. There is a growing need to incorporate the current requirements of pharmaceutical industries in the standard curriculum of pharmacy colleges to prepare the students with the latest developments to serve the industries. The present article discusses the regulatory education and its need, learning resources, courses available, syllabus contents, and job opportunities in regulatory affairs.